Returning from the RAPS Euro Convergence, in Lisbon, Portugal, we have several takeaways to share with you about the state of regulatory affairs, as concerns Pharma and Medical Devices in the European Union.
AI, as expected, took center stage as a primary topic of discussion, with workshop presenters and audience alike addressing the opportunities and challenges of this rapidly growing technology. How does AI fit into data collection, analysis, trials, safety control, product registrations, and every other aspect of health-care delivery?
The lingering concern among many, inside and outside of regulatory affairs—that AI will replace, at an accelerating rate, the role of people in productive activities—was largely dispelled. Rather the vital interaction between professionals and their technology tools was confirmed in many Q&A settings at the conference.
The move to further efficiencies, digitization, data storage, and information sharing was top-of-mind.
Another priority topic was the balance between speed-and accessibility for patients of newly registered products, on the one hand, versus the imperative for safety-control in the approval process. In this vein, there were numerous exchanges between representatives of the European Medical Agency and of industry.
The conference was filled with service providers specialized in digitized RA consulting, including approvals processing, after-market management, and the rapidly growing field of regulatory intelligence. WCS was able to emphasize the key and oft-neglected role of document-authentication—the final step in delivering products to overseas markets.
We spoke to RA support companies that reported regularly receiving clients’ documents with missing apostille stamps. These clients had the misunderstanding that the apostilles were unnecessary because they contained QR codes. Health authorities rejected these documents, and valuable time was lost while the documents were prepared again with the required stamps and authorizations.
As WCS continues to expand its global footprint, with affiliate services around the globe, we are grateful for the contacts made and the knowledge gained at Euro Convergence. In an increasingly global market, EU perspectives and EU regulations are of invaluable importance to the work we do on behalf of the Medical Device and Pharmaceutical communities.
Varghese George, CEO
Mitchell Torton, Director
Washington Consular Services
Metro Washington, DC, USA
Tel. USA 301 605 1500